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Pharaoh Neuro, a Minneapolis-based neurocritical care device company, has received FDA Breakthrough Device Designation for its Neurapheresis Cerebrospinal Fluid (CSF) Management System. The designation covers accelerated removal of blood and blood-breakdown products from the CSF of patients after aneurysmal subarachnoid hemorrhage (aSAH). The company is also participating in the FDA’s Total Product Lifecycle Advisory Program (TAP) Pilot, which together with the designation allows more frequent engagement with the agency.
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aSAH is a form of hemorrhagic stroke affecting about 30,000 people in the U.S. each year. Roughly one in four survivors does not return to functional independence, and an estimated two-thirds cannot return to prior employment. After the aneurysm is secured, standard care relies on passive drainage systems while blood gradually clears. The company says no cleared or approved device actively removes blood from the CSF.
Neurapheresis is an external, automated, closed-loop platform that aspirates, filters, and returns a patient’s CSF without introducing replacement fluids. Its safety and feasibility were evaluated in the PILLAR-XT trial, published in Neurocritical Care. Lead investigator Dr. Spiros Blackburn said patients “have very few new options.”
The system remains investigational, limited to use under an IDE, and has not been cleared or approved by the FDA. For the broader MedTech space, the designation adds to a steady flow of neurocritical care devices entering accelerated FDA pathways.
